Other safety alerts
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| Singapore: Recommendations on the use of codeine-containing products for treatment of pain and relief of cough and cold in children and adolescents |
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The Singapore Health Sciences Authority (HSA), in consultation with its Medicines Advisory Committee, has issued a Dear Healthcare Professional Letter to update healthcare professionals on the recommendations on the use of codeine-containing products for the treatment of pain and the relief of cough and cold in children and adolescents.
These recommendations have been made following concerns raised internationally on reports of deaths and severe respiratory depression in young children who received codeine following tonsillectomy and/or adenoidectomy for obstructive sleep apnoea.
HSA’s benefit-risk assessment considered the current available scientific evidence, adverse event reports in Singapore and the input of Singapore’s clinical experts. It was concluded that the benefit-risk profile of codeine remains favourable for restricted indications involving cough suppression and the short-term treatment of acute moderate pain in children 12 years old and above when administered at the lowest effective dose for the shortest possible duration.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/content/hsa/../recommendations-ontheuseofcodeinecontainingproductsfortreatmento.html
In Hong Kong, there are 320 registered pharmaceutical products containing codeine, which is an ingredient used to relieve pain and cough. News regarding the use of codeine in children was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 2012, with the last update posted on 2 October 2015. Letters to inform local healthcare professionals of the risk of respiratory depression were issued on 16 August 2012, and further letters on recommendation that codeine is restricted for use in children aged 12 and above were issued on 7 June 2013. So far, the Department of Health (DH) has received one adverse drug reaction case in connection with a codeine-containing cough and cold medicine, and it was not related to respiratory depression.
On 5 July 2013, the Registration Committee of the Pharmacy and Poisons Board decided that the sales pack label and/or package insert of pharmaceutical products containing codeine should be updated to include the relevant safety information. As previously reported on 2 July 2015, the US FDA has started evaluating the potential risk of serious side effects of codeine. DH will remain vigilant on the US FDA review's result and any safety updates of the drug by other overseas drug regulatory authorities for consideration of any further action deemed necessary.
Ends/ Tuesday, July 05, 2016
Issued at HKT 13:00
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